Press Release

WAYNE, Pa., April 24, 2019 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, today announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 10,265,258 covering methods of treating alopecia areata (AA) using ruxolitinib or isotopic forms of ruxolitinib. This newly issued patent is the latest in a series of patents granted by the USPTO which are exclusively licensed to Aclaris by The Trustees of Columbia University in the City of New York in connection with Aclaris’ janus kinase (JAK) inhibitor program for hair loss disorders. This IP arose out of the novel breakthrough research conducted by Dr. Angela Christiano and her team at Columbia University.

The claims in this issued patent cover the use of an effective amount of isotopic forms of ruxolitinib, including deuterated ruxolitinib, to treat AA. Concert Pharmaceuticals, Inc. is currently conducting Phase 2 trials for moderate-to-severe AA for its investigational drug, CTP-543, a deuterated form of ruxolitinib. Recently, in an inter partes review, the Patent Trial and Appeal Board ruled in favor of Incyte Corporation (which currently markets ruxolitinib under the tradename JAKAFI® (ruxolitinib tablets) for the treatment of polycythemia vera and myelofibrosis) regarding the invalidity of the composition of matter claims covering CTP-543 in Concert’s U.S. Patent No. 9,249,149. Concert has announced that it plans to appeal this decision.

 “We are extremely pleased with the continued expansion of the patent portfolio that we exclusively licensed from Columbia University,” said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.  “We believe access to this patent portfolio is necessary for anyone intending to commercialize ruxolitinib, deuterated ruxolitinib, and other JAK inhibitors to treat AA. We have spent considerable resources in licensing and prosecuting our JAK inhibitor patent portfolio and we intend to actively pursue opportunities provided to us by our patent rights covering the use of certain JAK inhibitors for the treatment of AA.”

Aclaris’ JAK inhibitor patent portfolio, exclusively licensed from Columbia University, also includes additional issued patents in the U.S. covering the use of ruxolitinib, tofacitinib, baricitinib, and decernotinib for the treatment of AA, androgenetic alopecia (AGA), and other hair loss disorders. Additional related patents have issued in Europe, Japan, and South Korea.

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of people with immuno-inflammatory and dermatological diseases who lack satisfactory treatment options. The company’s diverse and multi-stage portfolio includes two FDA-approved medicines, one late-stage investigational medicine, and a pipeline powered by a robust R&D engine exploring protein kinase regulation. Aclaris Therapeutics’ active development programs focus on areas where significant treatment gaps exist, such as common warts, alopecia areata, and vitiligo. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx. 

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the breadth and scope of our JAK Inhibitor patent portfolio. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2018, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings” section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Aclaris Contact
Michael Tung, M.D.
Senior Vice President 
Corporate Strategy/Investor Relations
484-329-2140
mtung@aclaristx.com

Source: Aclaris Therapeutics, Inc.